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Poli̇fleks

by Polifarma İlaç San. ve Tic. A.Ş. Türkiye EUDAMED

Ref 15000161, 15000179, 15000169, 15001004, 15000993, 15001017, 15000999, 15000159, 15000177, 15000163, 15000165, 15000998, 15000157, 15001010, 15001007Model PP BAG 150 ML, PP BAG 500 ML, PP BAG 750 ML, PVC BAG 500 ML, PVC BAG 50 ML, PVC BAG 1500 ML, PVC BAG 1000 ML, PP BAG 100 ML, PP BAG 350 ML, PP BAG 250 ML, PP BAG 50 ML, PP BAG 2000 ML, PVC BAG 2000 ML EMDN A03040299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08699606613961 Basic UDI-DIDate25 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Sterile Distilled Water Irrigation Solution
0.9% Isotonic Sodium Chloride Irrigation Solution
1.5% Glycine Urologic Irrigation Solution
Model / Reference
PP BAG 150 ML, 15000161, PP BAG 500 ML, 15000179, PP BAG 750 ML, 15000169, PVC BAG 500 ML, 15001004, PVC BAG 50 ML, 15000993, PVC BAG 1500 ML, 15001017, PVC BAG 1000 ML, 15000999, PP BAG 100 ML, 15000159, PP BAG 350 ML, 15000177, PP BAG 250 ML, 15000163, 15000165, 15000998, PP BAG 50 ML, 15000157, PP BAG 2000 ML, 15001010, PVC BAG 2000 ML, 15001007
Primary DI / UDI-DI
08699606613961, 08699606684183, 08699606684190, 08699606684244, 08699606615064, 08699606684947, 08699606615118, 08699606613954, 08699606684312, 08699606613978, 08699606613985, 08699606615101, 08699606613947, 08699606684213, 08699606684275
Basic UDI-DI
B-08699606613961, B-08699606684183, B-08699606684190, B-08699606684244, B-08699606615064, B-08699606684947, B-08699606615118, B-08699606613954, B-08699606684312, B-08699606613978, B-08699606613985, B-08699606615101, B-08699606613947, B-08699606684213, B-08699606684275
EMDN Code
A03040299 Irrigation kits, single-use - other
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000023645

Other devices from Polifarma İlaç San. ve Tic. A.Ş.

See all devices from Polifarma İlaç San. ve Tic. A.Ş. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (15)

  • EUDAMED afd8a8e9-eef2-4f67-ad2f-babddf7fc093 61 fields · synced 22 Oct 2026
  • EUDAMED 08699606684183|B-08699606684183 61 fields · synced 17 May 2026
  • EUDAMED 08699606684190|B-08699606684190 61 fields · synced 17 May 2026
  • EUDAMED 08699606684244|B-08699606684244 61 fields · synced 17 May 2026
  • EUDAMED 08699606615064|B-08699606615064 61 fields · synced 17 May 2026
  • EUDAMED 08699606684947|B-08699606684947 61 fields · synced 17 May 2026
  • EUDAMED 08699606615118|B-08699606615118 61 fields · synced 17 May 2026
  • EUDAMED 08699606613954|B-08699606613954 61 fields · synced 17 May 2026
  • EUDAMED 08699606684312|B-08699606684312 61 fields · synced 18 May 2026
  • EUDAMED 08699606613978|B-08699606613978 61 fields · synced 18 May 2026
  • EUDAMED 08699606613985|B-08699606613985 61 fields · synced 18 May 2026
  • EUDAMED 08699606615101|B-08699606615101 61 fields · synced 19 May 2026
  • EUDAMED 08699606613947|B-08699606613947 61 fields · synced 19 May 2026
  • EUDAMED 08699606684213|B-08699606684213 61 fields · synced 19 May 2026
  • EUDAMED 08699606684275|B-08699606684275 61 fields · synced 19 May 2026